The main objective of this study is to investigate the effect of probiotics on the sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as total faecal output, relative faecal dry weight and mucin excretion in…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal infections
- Immune disorders NEC
Synonym
Health condition
Populatie van bacterien in de darm en algemene gezondheid en "innate immunity"
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percent change in faecal dry weight and total
faecal output between the probiotics group and the placebo group
Secondary outcome
In addition, intestinal permeability, inflammation and other clinical symptoms
will be evaluated.
Background summary
Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the
proximal intestines and an infection is therefore a local and relevant
challenge for the intestines, giving an indication of general resistance and/or
the local resistance of the intestines. We will evaluate the effects of
probiotics by comparing the infection symptoms and by measuring faecal weight
and mucus in faeces. The sequel of events of mucosal inflammation will be
characterized in this study and biomarkers for these sequels will be evaluated
Study objective
The main objective of this study is to investigate the effect of probiotics on
the sequels of ETEC administration as intestinal permeability, inflammation and
clinical signs as total faecal output, relative faecal dry weight and mucin
excretion in faeces. In addition biomarkers for intestinal health and
onflammation will be evaluated.
Study design
The study is designed as a randomized, parallel, placebo-controlled,
double-blind study. Study substance (probiotics) and placebo will be given
during 4 weeks.
Intervention
One group receives twice daily two sachets containing 450 billion live
freeze-dried lactic acid bacteria per sachet and the other group receives twice
daily a two placebo sachets. On day 21 all volunteers will be infected with an
attenuated ETEC strain to induce mild traveler's diarrhoea.
Study burden and risks
In this study healthy male volunteers will be challenged with an attenuated
ETEC strain after three week of either probiotics or placebo. This infection
will lead to a mild traveller*s diarrhoea in the subjects during approximately
three days maximally. Sequels of this infection and the effects of commercially
available probiotics compared to placebo will be followed up. The subjects will
therefore collect their faeces on several days, record their defecation pattern
and gastro-intestinal complaints during four weeks, undergo a physical
examination and five venapunctions, and visit our facilities in total on 8 days
(excluding two pre-study visits). The oral administration of probiotics in a
healthy population is not associated with risk
Postbus 360
3700 AJ Zeist
NL
Postbus 360
3700 AJ Zeist
NL
Listed location countries
Age
Inclusion criteria
1. Healthy as assessed by the
- health and lifestyle questionnaire, (P9067 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
2. Males, Age 21 - 40 years at Day 01 of the study
3 Body Mass Index (BMI) >20 and < 33 kg/m2. Preferably in high and low body fat mass ranges as to be determined by waist circumference
4 Normal Dutch eating habits as assessed by P9067 F02
5 Voluntary participation
6 Having given written informed consent
7 Willing to comply with the study procedures, including the ETEC challenge
8 Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
9 Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
Subjects with one or more of the following characteristics will be excluded from participation:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
3. Having a history of medical or surgical events that may significantly affect the study outcome, including gastrointestinal illness or surgical operations,
4. Use of antibiotics, immunosuppressive drugs, antacids, laxatives or antidiarrheal drugs in the last 3 months before the study
5. Alcohol consumption > 28 units/week for males .
6. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
7. Reported slimming or medically prescribed diet
8. Reported vegan, vegetarian or macrobiotic
9. Working as a food handler, in child care or as a healthcare worker with direct patient contact
10. Not willing to give up blood donation during the study.
11. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
12. Not having a general practitioner
13. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33744.028.10 |